Trial Outcomes & Findings for Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis (NCT NCT03235024)

NCT ID: NCT03235024

Last Updated: 2022-10-10

Results Overview

Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

Baseline to Day 42

Results posted on

2022-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	B244 B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Overall Study STARTED	61	61
Overall Study COMPLETED	55	51
Overall Study NOT COMPLETED	6	10

Reasons for withdrawal

Reasons for withdrawal
Measure	B244 B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Overall Study Adverse Event	2	2
Overall Study Death	1	0
Overall Study Lost to Follow-up	2	5
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B244 n=61 Participants B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle n=61 Participants Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension	Total n=122 Participants Total of all reporting groups
Age, Customized < 30 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Customized ≥ 30 years	49 Participants n=5 Participants	49 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	44 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	17 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	50 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Weight	85.420 kg STANDARD_DEVIATION 24.9020 • n=5 Participants	85.542 kg STANDARD_DEVIATION 22.8794 • n=7 Participants	85.481 kg STANDARD_DEVIATION 23.8132 • n=5 Participants
BMI	30.027 kg/m^2 STANDARD_DEVIATION 9.2237 • n=5 Participants	30.551 kg/m^2 STANDARD_DEVIATION 7.0286 • n=7 Participants	30.289 kg/m^2 STANDARD_DEVIATION 8.1702 • n=5 Participants
BMI Category <20 kg/m^2	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
BMI Category 20 to <25 kg/m^2	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
BMI Category 25 to <30 kg/m^2	12 Participants n=5 Participants	22 Participants n=7 Participants	34 Participants n=5 Participants
BMI Category ≥30 kg/m^2	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Smoking History Never	32 Participants n=5 Participants	39 Participants n=7 Participants	71 Participants n=5 Participants
Smoking History Former	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Smoking History Current	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 42

Population: Intent to Treat (ITT) population included all randomized subjects.

Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.

Outcome measures

Outcome measures
Measure	B244 n=61 Participants B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle n=61 Participants Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 At Least 1 Treatment-Related TEAE	2 Participants	4 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 At Least 1 Treatment-Related Grade 3 or 4 TEAE	0 Participants	0 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 At Least 1 Treatment-Related Serious TEAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Day 28

Population: Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.

EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.

Outcome measures

Outcome measures
Measure	B244 n=56 Participants B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle n=51 Participants Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups	-5.7 score on a scale Standard Deviation 4.46	-5.9 score on a scale Standard Deviation 5.90

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Day 28

Population: Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.

VAS (Visual Analog Scale) was performed as a measure of pruritus. The VAS is composed of a 10-cm line divided into a scale from 0 to 10, and subjects were to indicate the score that best represented the intensity of their itching over the 24-hour period before each visit where a higher score indicated greater severity in pruritus.

Outcome measures

Outcome measures
Measure	B244 n=56 Participants B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle n=51 Participants Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group Week 2 Change from Baseline	-1.5 score on a scale Standard Deviation 2.23	-0.6 score on a scale Standard Deviation 1.92
Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group Week 4 Change from Baseline	-1.8 score on a scale Standard Deviation 2.81	-1.4 score on a scale Standard Deviation 2.32

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Day 28

Population: Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.

The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.

Outcome measures

Outcome measures
Measure	B244 n=56 Participants B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle n=51 Participants Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Change in the Skindex 16 Score Between the Active and Vehicle Group	-0.2 score on a scale Standard Deviation 5.74	-0.8 score on a scale Standard Deviation 1.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Day 28

Population: Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28.

IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).

Outcome measures

Outcome measures
Measure	B244 n=56 Participants B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle n=51 Participants Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Change in the IGA Score Between the Active and Vehicle Groups	-0.6 score on a scale Standard Deviation 0.82	-0.7 score on a scale Standard Deviation 0.94

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Day 28

Population: Subjects from the Intent to Treat (ITT) population (all randomized subjects) that remained in the study at Day 28 with data collected from Actigraphy watches (subjects with missing data were excluded from analysis).

Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.

Outcome measures

Outcome measures
Measure	B244 n=7 Participants B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle n=4 Participants Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group	-3.4 average scratching events per hour Standard Deviation 8.26	3 average scratching events per hour Standard Deviation 7.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Day 28

Population: Data was not collected for this exploratory endpoint.

To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Day 28

Population: Data was not collected for this exploratory endpoint.

Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.

Outcome measures

Outcome data not reported

Adverse Events

B244

Serious events: 1 serious events

Other events: 16 other events

Deaths: 1 deaths

Vehicle

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	B244 n=61 participants at risk B244 suspension (4x10E9 cells/ml) in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day B244: B244 suspension	Vehicle n=61 participants at risk Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day Vehicle: Vehicle suspension
Vascular disorders Arteriosclerosis	1.6% 1/61 • Number of events 1 • Baseline to Week 6. All AEs occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. Adverse events believed to be possibly related to IP must have been followed until their resolution.	0.00% 0/61 • Baseline to Week 6. All AEs occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. Adverse events believed to be possibly related to IP must have been followed until their resolution.

Other adverse events

Additional Information

Hyun Kim, Vice President Clinical Operations

AOBiome Therapeutics

Phone: 617-639-9980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor shall have 45 days to review the papers. Sponsor shall have the right to require Institution/Principal Investigator, as applicable, to remove specifically identified confidential information and/or delay the proposed publication or presentation for an additional one hundred twenty (120) days to enable Sponsor to seek patent protections.
Publication restrictions are in place

Restriction type: OTHER